FDA lands a rare victory in First Amendment case

Medical Marketing and Media, Mar 2003 by Dickinson, James G

The FDA halted its steady downward spiral on First Amendment issues in federal court in January when District of Columbia federal judge Gladys Kessler found that the agency did not violate the First Amendment when it suppressed a dietary supplement maker's claim that saw palmetto extract may help treat symptoms associated with mild benign prostatic hyperplasia. For several years, the FDA has been consistently losing such cases,

The case at issue this time, however, was decided more on what constitutes a permitted health claim and less on the suppression of commercial speech.

In one of two closely related actions each known as Whitaker v. Thompson, plaintiffs argued that the FDA should have evaluated the saw palmetto claim as a permitted health claim and not as a drug claim. The FDA disagreed, contending that the statute only allows disease prevention-related claims and mandates the denial of any claims falling outside of that scope. In her ruling, Kessler said that because the statutory language was ambiguous, the FDA was entitled to deference in its decision to exclude claims of an effect on an existing disease from its permitted health claim definition.